The present invention relates generally to a device for covering and protecting external fixation devices. External fixation devices are used for stabilization of bony elements in order to allow for bone healing following a fracture or dislocation. These external fixation devices may also be utilized following a surgical realignment of the bones (osteotomy) as well as for intentional fusion of arthritic joints. Typically, the devices are engaged to the peripheral skeletal structures. The invention contemplates devices and methods for providing a protective and cosmetic covering to the external fixation device.
An external fixation device is a stabilization system consisting of a system of threaded and smooth pins fixed to the bony elements which are then anchored to a ring or bar structure for stabilization. Rods are used to link the ring elements and provide for stability between the elements during healing. External fixators F are very bulky, as shown in FIGS. 1 and 2 (for the lower extremity) and FIGS. 3 and 4 (for the upper extremity). When used for definitive skeletal fixation or joint fusion, these structures are applied to the skeletal elements for long lengths of time, typically ranging from six weeks to six months. If the structure is placed on the lower limb and incorporates the boney elements of the foot, provision may be made for ambulation by attachment of a base plate and rubber sole or a modified shoe to the fixation system. However, no provision is made for any external covering to the fixation system.
Currently, coverings are can be provided for plaster casts that may be applied to the skeletal system. Casts are smaller and lower profile and more easily provided with a fabric covering. These coverings may be commercially available or may be easily fabricated by the patients. It may even be possible to utilize a large sock to cover the plaster cast. Where the cast is applied to the lower limb, a walking cast may incorporate a rubber insert into the plaster or a separate fabric boot B held by VELCRO® straps that wrap around the cast, as depicted in FIG. 5. Specialized coverings have been designed to allow for water-proofing of the plaster, as shown in FIG. 6.
A covering entity for an external fixator would provide for multiple benefits to the patient. First, the external fixation system is not aesthetically appealing and a covering would give both adult and pediatric patients an enhanced personal image by covering the pins protruding from the skin and the unsightly framework of the fixation system. Patients may be reluctant to be in public view with the complex fixation elements protruding from their upper or lower limbs. Pins protruding openly from the skin and the complex fixation frame are a likely source of unwanted attention in public. Especially in the pediatric population, the embarrassment of the presence of the external fixation system may lead to distress as peers in school point to the device and ask questions. For children, the opportunity to cover the device would be of great benefit.
Secondly, a protective covering can provide enhanced patient comfort from nature's elements, such as cold or wet conditions. Third, a covering may act to reduce the likelihood of infection along the pin tracks, a well recognized complication of external fixation devices. Moreover, a covering for the external fixator F will preserve the durability of the fixation element anchorage and any skin bandages associated with the implantation of the fixator. Given the long duration of the fixation time, the fixator and instrumentation site are exposed daily to a variety of debris. Bacterial contamination from airborne particles, as well as debris or spills, may travel along the fixation system and reside at the skin-implant interface. Pin tract infections are a serious complication, requiring local debridement and potentially removal of all or part of the infected fixation device prior to its intended duration of treatment. Reducing exposure of the fixator and skin interface will greatly reduce the risk of these complications.
What is needed is a protective covering that meets all of these desirable qualities and that is easily used by the patient.